A new revision of the Declaration of Helsinki was published last October following the 64th World Medical Association General Assembly. The official versions in English, French and Spanish (*) are available on the WMA website. I have used the official English and Spanish versions to produce the parallel text below.

The Declaration of Helsinki is often attached as an annex to clinical trial protocols and over the years I have added the 2004 and 2008 versions to my translation memory. With this new 2013 release I prepared the English and Spanish versions in Word, aligned them with Studio 2014 and saved the result as a Studio TM. I used the SDL XLIFF converter for MS Office to export the file to Excel so that I could display the parallel text in table format below.

How to convert the text into a translation memory:

Copy and paste the two columns in an Excel file.

Save as a tab delimited text file in Excel (extension .txt).

Open the file in Studio. (Check beforehand that the source and target columns in the tab delimited text file type match your Excel columns in Project settings>File Type>Tab Delimited Text>Format.)

Save the SDLXLIFF file and import it into your TM.

The WMA kindly gave me permission to reproduce this WMA policy after 1 January 2014, as per the copyright notice that appears under the bilingual table.

The World Medical Association (WMA) has developed the Declaration of Helsinki as a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments).

It is the duty of physicians who are involved in medical research to protect the life, health, dignity, integrity, right to self-determination, privacy, and confidentiality of personal information of research subjects.

The responsibility for the protection of research subjects must always rest with the physician or other health care professionals and never with the research subjects, even though they have given consent.

Physicians who combine medical research with medical care should involve their patients in research only to the extent that this is justified by its potential preventive, diagnostic or therapeutic value and if the physician has good reason to believe that participation in the research study will not adversely affect the health of the patients who serve as research subjects.

All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.

Medical research with a vulnerable group is only justified if the research is responsive to the health needs or priorities of this group and the research cannot be carried out in a non-vulnerable group.

Medical research involving human subjects must conform to generally accepted scientific principles, be based on a thorough knowledge of the scientific literature, other relevant sources of information, and adequate laboratory and, as appropriate, animal experimentation.

The protocol should include information regarding funding, sponsors, institutional affiliations, potential conflicts of interest, incentives for subjects and information regarding provisions for treating and/or compensating subjects who are harmed as a consequence of participation in the research study.

It must take into consideration the laws and regulations of the country or countries in which the research is to be performed as well as applicable international norms and standards but these must not be allowed to reduce or eliminate any of the protections for research subjects set forth in this Declaration.

In medical research involving human subjects capable of giving informed consent, each potential subject must be adequately informed of the aims, methods, sources of funding, any possible conflicts of interest, institutional affiliations of the researcher, the anticipated benefits and potential risks of the study and the discomfort it may entail, post-study provisions and any other relevant aspects of the study.

After ensuring that the potential subject has understood the information, the physician or another appropriately qualified individual must then seek the potential subject’s freely-given informed consent, preferably in writing.

When seeking informed consent for participation in a research study the physician must be particularly cautious if the potential subject is in a dependent relationship with the physician or may consent under duress.

These individuals must not be included in a research study that has no likelihood of benefit for them unless it is intended to promote the health of the group represented by the potential subject, the research cannot instead be performed with persons capable of providing informed consent, and the research entails only minimal risk and minimal burden.

When a potential research subject who is deemed incapable of giving informed consent is able to give assent to decisions about participation in research, the physician must seek that assent in addition to the consent of the legally authorised representative.

Research involving subjects who are physically or mentally incapable of giving consent, for example, unconscious patients, may be done only if the physical or mental condition that prevents giving informed consent is a necessary characteristic of the research group.

If no such representative is available and if the research cannot be delayed, the study may proceed without informed consent provided that the specific reasons for involving subjects with a condition that renders them unable to give informed consent have been stated in the research protocol and the study has been approved by a research ethics committee.

For medical research using identifiable human material or data, such as research on material or data contained in biobanks or similar repositories, physicians must seek informed consent for its collection, storage and/or reuse.

Where for compelling and scientifically sound methodological reasons the use of any intervention less effective than the best proven one, the use of placebo, or no intervention is necessary to determine the efficacy or safety of an intervention

and the patients who receive any intervention less effective than the best proven one, placebo, or no intervention will not be subject to additional risks of serious or irreversible harm as a result of not receiving the best proven intervention.

In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial.

In the treatment of an individual patient, where proven interventions do not exist or other known interventions have been ineffective, the physician, after seeking expert advice, with informed consent from the patient or a legally authorised representative, may use an unproven intervention if in the physician’s judgement it offers hope of saving life, re-establishing health or alleviating suffering.

21 Responses to Declaration of Helsinki, October 2013, aligned in English and Spanish

Thanks for your post. It’s good to have both the English and Spanish version of this declaration.. However, having even more languages would be even better. I wonder if they’ll ever come out with a Swedish version.

Thank you so much for sharing, Emma. Although I don’t do – as a rule – medical translations, sometimes I have to and this may come in very handy. Unfortunately I cannot profit of your instructions on how to import the versions into my TM because I don’t have Trados (my CAT is Wordfast Classic). However, and despite these being official versions, in a quick once-over, I have noticed several translation errors (as I am sure you must have) in the Spanish version; for instance “inconclusive” is translated as “inconclusos” which is a false friend, because “inconclusive” does not mean unfinished (inconclusos) but “no concluyentes” (in the sense of not final). This just to mention an example. And that is where we, as human translators, enter the scene! :). Thanks again for a stupendous contribution!

Hi Nélida.
Thanks for your comment. Another conversion method that could work for you would be to import the .txt into Xbench and export it in TMX format. You can download Xbench 2.9 for free at http://www.xbench.net/
The latest version, 3.0, is a subscription version but is definitely worthwhile for Studio users because it supports all Studio formats. More about this in a future blog post…

I agree that the Spanish translation could be improved. I had to read point 29 several times and refer back to the English to understand its meaning. “Potential research subject” isn’t exactly an “individuo potencial que participa en la investigación”.
Happily for me, the English version is well written, but I do sympathise with into Spanish translators.

Thanks for the conversion tip, Emma, much appreciated.
On the subject of translatioin quality, had to laugh about the “individuo potencial” (a potential person? a fetus?). I concur that the English is well written, as opposed to the into Spanish translation, so I tend to sympathize more with the into English translators if they should have to depart from such Spanish text as source, LOL.
Have a splendid weekend!

Great post!
I hope, too, that non translators who chance upon your post realise that translators need pretty long concentration spans to do their work effectively. This is just a small sample of what we are capable of producing in an average day. Could you give the word counts in each language at the bottom, perhaps, Emma? You know, two to three thousand words per day rolls so easily of the tongue, doesn’t it?
Thank you Nelida for pointing out weaknesses in the Spanish translation. I bet there are a lot of Spanish-challenged (like me) translators who nevertheless read the whole post segment for segment in both English and Spanish… :)

Hi Allison,
I’ve just looked up the word count: the English text has 2355 words and the Spanish has 2563, which (incidentally) confirms the general rule that Spanish texts have 10% more words than their equivalent in English. Definitely an important consideration when charging by source or target word count.

With regard to word output per day, I agree that 2000 words are possible in one day, although if it’s a text that requires a lot of research or very careful wording, I’d say I don’t do more than 1000. That’s where CAT tools really come into their own, because anyone who has read this blog post is now able to translate the Declaration of Helsinki into or out of Spanish in about 15 minutes!

Ha! That’s what I call leverage!
I agree with the 1,000 words per day for complex texts requiring solid research. That was my average for publication-ready translation of a 125,000-word work on grapevines. That was *without* a CAT tool of any description, although this particular text did not have that many repetitions. The work would have made a fantastic TM/Concordance for future reference, though, if typos in the ST were sorted out prior to translation. :)